Proper sterilization of medical devices is necessary to reduce chances of infection caused by using these devices. A contaminated medical device will lead to device-induced infection, thereby do more harm than good to the patient. Hence, while manufacturing medical devices, elimination of harmful microorganisms contaminating medical devices is a must. Thus, medical device sterilization is of vital importance to prevent infection and ensure the safety of patients and medical professionals. Therefore, sterilization of medical devices is a critical component of the medical device manufacturing process. In certain cases, manufacturers prefer to outsource the sterilization of medical devices. We have mentioned the latest regulatory update for outsourcing medical device sterilization.
The medical device sterilization activity is commonly outsourced. However, stake holders have raised concerns regarding the requirement for loan license for outsourcing sterilization at the site of another facility having valid license to carry out the sterilization process under Medical Device Rules, 2017. The loan license is usually used by a company without a manufacturing facility to manufacture medical devices. With the loan license, the company can use the manufacturing facility of another company that is manufacturing the same product. However, stake holders have voiced concerns regarding the requirement for loan license for outsourcing medical device sterilization. The Drugs Consultative Committee (DCC) in its 61st meeting, held on 01.06.2023, had deliberated the matter. It recommended the constitution of a sub-committee for suitable recommendation on the matter. The recommendations were placed in the 65th DCC meeting on 20.12.24. The DCC agreed to the recommendations and placed certain requirements.
What is medical device sterilization?
Sterilization of medical devices is the process of destroying microbial contamination on medical devices till they can be safely used in the healthcare industry. All forms of microbes have to be destroyed to ensure patient and end user safety. Depending on the nature of the medical device and its intended use, medical devices can be sterilized using various methods. Physical or chemical methods are used for sterilization of medical devices. Medical device sterilization methods are regulated by the applicable regulatory body. We have listed some common medical device sterilization methods.
Common medical device sterilization methods
- Steam Sterilisation: Steam sterilisation is the most common sterilization method. It is the least expensive of all medical device sterilization methods and is non-toxic.
- Vapour phase sterilization: Although this technique is similar to steam sterilisation, it may be a little faster than steam sterilisation.
- Dry heat sterilization: Owing to the absence of steam or water, dry heat sterilization does not usually cause corrosion. A major disadvantage of this method is that it is time consuming.
- Radiation sterilization: Radiation sterilization is a rapid process. This technique is ideal for single-use medical devices.
- Ethylene oxide sterilization: Unlike heat-based methods, such as steam and dry heat, this method can be used on a variety of materials without distorting or damaging the device.
- Filtration sterilisation: This technique employs a sterilising filter to sterilise the medical device. This method is particularly used for medical devices loaded with biologics.
- Liquid sterilisation: In this method, liquid chemical agents are used to sterilize medical devices. This is one of the less common medical device sterilization methods used in the industry.
We have presented some common medical device sterilization methods. Notably, goal of sterilization is to eliminate microorganisms contaminating the medical devices with minimal negative effect on the device. Hence, it is important to carefully choose a sterilization method appropriate for your medical device.
The primary goal of medical device sterilization is to prevent infection and ensure the safety of patients and medical professionals. Irrespective of the intended use and risk level of the medical device, patient and user safety have to be ensured. Hence, elimination of harmful microorganisms contaminating medical devices by means of sterilization is a must while manufacturing devices.
Outsourcing medical device sterilization: Latest regulatory update
Medical device manufacturers often outsource the medical device sterilization process. CDSCO has updated the guidelines and regulatory requirement for outsourcing medical device sterilization.
- Loan license requirement: Loan license is not necessary for outsourcing medical device sterilization. This is because the final product is released from the actual manufacturing site and manufacturer is monitoring the entire QC check before release. The sterilization activity will be performed by way of mutual third-party agreement. This agreement will be permitted only if the facilities shall have the license to perform the sterilization process under MDR, 2017.
- Valid sterilization license: The sub-committee has highlighted that the manufacturer in whose premises the sterilization process will be carried out must have valid sterilization license. The license should be for the medical device for which the actual manufacturer is holding the manufacturing license.
- Sterilization site license number: Medical device sterilization is a crucial component of the medical device manufacturing process. Hence, the medical device manufacturer is expected to mention the license number of the outsourced sterilization site on the device label. Additionally, the sub-committee has suggested that this outsourcing medical device sterilization activity requirement be included in Rule 44 of the MDR-2017 as part of the labelling requirements.
Latest regulatory requirements for outsourcing sterilization activity of medical devices
The Drugs Consultative Committee (DCC) has agreed to the above recommendations of the sub-committee. Additionally, it has mentioned certain regulatory requirements for outsourcing sterilization activity of medical devices.
- Prior to obtaining the manufacturing license, documentary evidence in support of outsourcing medical device sterilization has to be submitted to the licensing authority.
- The documentary evidence is expected to include mutual agreement between the manufacturer of the device and the sterilization site, quality management system document (Plant master file, Device master file, etc.) of the manufacturer mentioning the details of such outsourced activity, etc.
- License number of the outsourced sterilization site should also be mentioned on label of the device.
All of the above DCC recommendations had been placed in the 92nd drugs technical advisory board (DTAB) meeting held on 24.04.2025 for further consideration. Notice, dated 24.6.25, has stated that the DTAB has reviewed the matter and agreed to the recommendations.
Pharmadocx Consultants: Your trusted regulatory ally
The CDSCO medical device regulations are dynamic and constantly being updated to improve the healthcare services delivered. Compliance with Indian medical device regulations is a mandatory requirement to launch your product in India. As medical device manufacturers, it is not possible to always stay abreast of the latest regulatory guidelines. This is where our team of experts come in. We at Pharmadocx Consultants have extensive knowledge of the CDSCO regulatory requirements for medical devices in India. Our team has in-depth industry expertise. We will leverage our expertise to help you easily navigate the medical device regulatory framework in India. We offer the following services to medical device manufacturers:
- Designing facility layouts per regulatory guidelines
- Technical document preparation
- Application filing
- Implementation of QMS
- License application submission support
- Mock audit service
- CDSCO query response
- Post license support
Our team will utilize their expertise and industry knowledge to help you establish your medical device manufacturing business without any regulatory hassle. For any queries on outsourcing medical device sterilization or any other regulatory query, feel free to email at [email protected] or call/Whatsapp on 9996859227. Our goal is to help medical device manufacturers have a smooth regulatory journey and easily launch their medical device business.
